POVIDONE-IODINE PREP SWABSTICK- povidone-iodine solution

Povidone-Iodine Prep Swabstick by

Drug Labeling and Warnings

Povidone-Iodine Prep Swabstick by is a Otc medication manufactured, distributed, or labeled by H and P Industries, Inc. dba Triad Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone Iodine USP 10% w/v (equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USES

• Health Care Antiseptic for preparation of the skin prior to surgery

• First Aid Antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
  

WARNINGS

For external use only.

Do not

• use in the eyes
• apply over large areas of the body
• use on individuals who are allergic or sensitive to iodine
• use as a first aid antiseptic for longer than 1 week unless directed by a doctor

Ask a doctor in case of

• deep or puncture wounds
• animal bites
• serious burns
  

Stop use and ask a doctor

• if condition persists for more than 72 hours
• if irritation and redness develop
  

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

For preparation of the skin prior to surgery

• clean the affected area
• remove swab by stick
  
• apply to the operative site prior to surgery

As a first aid antiseptic

• clean the affected area
• apply a small amount of this product to the area 1-3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first
  

SPL UNCLASSIFIED SECTION

OTHER INFORMATION

Store at room temperature 15° - 30° C (59° - 86° F)

INACTIVE INGREDIENTS

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

QUESTIONS

POUCH INFORMATION

TRIAD

Cat. No. 10-4101
NDC: 50730-4101-1

10% Povidone Iodine, USP
POVIDONE IODINE
SWABSTICKS (1's)

Antiseptic / Germicide
For Hospital and Professional Use Only

Triad Disposables, Inc.
Brookfield, WI 53045 USA

Contents:
1 Swabstick

CARTON INFORMATION

TRIAD

Cat. No. 10-4101
NDC: 50730-4101-1

10% Povidone Iodine, USP
POVIDONE IODINE
SWABSTICKS (1's)

Antiseptic / Germicide
For Hospital and Professional Use Only

Triad Disposables, Inc.
Brookfield, WI 53045 USA

Contents:
50 Pouches
1 Swabstick per Pouch

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP SWABSTICK 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50730-4101
Route of Administration	TOPICAL, EPIDURAL, PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M)	povidone-iodine	.10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
sodium hydroxide (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50730-4101-1	50 in 1 BOX
1		1 in 1 POUCH
1		1.7 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	06/21/1985

Labeler - H and P Industries, Inc. dba Triad Group (050259597)

Registrant - H and P Industries, Inc. dba Triad Group (050259597)

Establishment
Name	Address	ID/FEI	Business Operations
H and P Industries, Inc. dba Triad Group		050259597	manufacture